Evaluation of the Effect of Citicoline and Docosahexaenoic Acid (DHA) on the Visual Function of Patients With Glaucoma

NCT05527106 | Completed

• 1 other identifier: ICR-14/13
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

Pilot, single-blind, randomized and controlled study to evaluate the changes produced in the visual function of patients with glaucoma after oral administration for 3 months of citicoline and docosahexaenoic Acid (DHA) vs citicoline and docosahexaenoic Acid (DHA) vs vitamin C.

Conditions

Glaucoma

Keywords

glaucoma; nutraceuticals; dha (docosahexaenoic acid); citicoline

Outcome Measures

Primary Outcomes (2)

• Effect on Mean Defect (MD)

  Evaluation of changes on the MD (decibels) with study treatment.

  From Baseline to Month 3.

• Effect on Visual Field Index (VFI)

  Evaluation of changes on the VFI (%) with study treatment.

  From Baseline to Month 3.

Secondary Outcomes (2)

• Evaluation of the changes produced in the intraocular pressure (IOP)

  From Baseline to Month 3.

• Evaluation of tolerance

  From Month 1 to Month 3

Study Arms (4)

Citicoline

EXPERIMENTAL

Cebrolux 800 is a food supplement based on citicoline (163 mg) that also contains vitamin A, E, C and B6.

Dietary Supplement: Citicoline

Docosahexaenoic Acid (DHA)

EXPERIMENTAL

Brudypio 1.5g is a food supplement based on Omega-3 fatty acid in the form of triglycerides (DHA 70% \[350 mg\], EPA 8.5%, DPA 6%) that also contains vitamins (A, B1, B2, B3, B6, B9, B12, C, E), carotenoids ( lutein, zeaxanthin, lycopene), glutathione, coenzyme Q10 and minerals (Zn, Se, Cu, Mn).

Dietary Supplement: Docosahexaenoic Acid (DHA)

Citicoline and Docosahexaenoic Acid (DHA)

EXPERIMENTAL

Cebrolux 800 and Brudypio 1.5g (see above).

Dietary Supplement: Citicoline and Docosahexaenoic Acid (DHA)

Vitamin C

EXPERIMENTAL

Vitamin C.

Dietary Supplement: Vitamin C

Interventions

Citicoline DIETARY_SUPPLEMENT

Every subject randomized into this group have to take 2 sachets of Cebrolux 800 (362 mg of citicoline per day), every day, for 3 months.

Also known as: Cebrolux 800

Citicoline

Docosahexaenoic Acid (DHA) DIETARY_SUPPLEMENT

Every subject randomized into this group have to take 3 pills of Brudypio 1.5g (1050 mg of DHA per day), every day, for 3 months.

Also known as: Brudypio 1.5g

Docosahexaenoic Acid (DHA)

Citicoline and Docosahexaenoic Acid (DHA) DIETARY_SUPPLEMENT

Every subject randomized into this group have to take 2 sachets of Cebrolux 800 and 3 pills of Brudypio 1.5g per day, every day, for 3 months.

Citicoline and Docosahexaenoic Acid (DHA)

Vitamin C DIETARY_SUPPLEMENT

Every subject randomized into this group have to take 1 pills of Vitamin C (500 mg per day), every day, for 3 months.

Also known as: L-ascorbic acid

Vitamin C

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with chronic, primary or secondary, open or closed angle glaucoma, diagnosed by meeting the following criteria:
• Signs of structural damage: thinning of the optical nerve or peripapillary hemorrhage or decrease in the nerve fiber layer that can be seen by OCT.
• Signs of functional damage: 3 points outside 95% of the normal limit on the visual field pattern deviation graph.
• There must be at least 3 reliable visual fields prior to the start of the study.
• Patients between 50 and 75 years old, homogeneously distributed among the groups.
• Glaucoma with functional and structural damage.
• Medium grade, Mean Deviation (MD) between -4 and -20 dB.
• In at least one eye.

You may not qualify if:

• Treatment with some other vitamin or nutraceutical preparation.
• Any pathology that can alter the visual field. (Neurological diseases, retinopathies, advanced cataract, patients treated with lyrica (due to the affectation it produces in the visual field)).
• Hypersensitivity to aspirin. (Cross-allergic reaction has been reported in patients taking citicoline.)
• Allergic to fish protein.
• Eye surgery in the 3 months before or during the study.

Sponsors & Collaborators

• Institut Catala de Retina: lead

Study Sites (1)

Institut Catala de Retina

Barcelona, 08022, Spain

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Cytidine Diphosphate Choline; Docosahexaenoic Acids; Ascorbic Acid

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Choline; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Cytidine Diphosphate; Cytosine Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides; Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Hydroxy Acids; Carbohydrates

Study Officials

• Alfonso Anton, MD, PhD

  Institut Catala de Retina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: September 2, 2022
• Study Start: March 12, 2015
• Primary Completion: May 25, 2022
• Study Completion: May 25, 2022
• Last Updated: September 2, 2022

Record last verified: 2022-09

Locations

ES (1)